BridgeMD
New treatment option for Sarcopenia in Elderly
Official title A Study of PLH-2301 in Subjects With Sarcopenia
ClinicalTrials.gov ID: NCT07390552
What this study is testing
What is PLH-2301?
PLH-2301 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sarcopenia in elderly.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of PLH-2301 in subjects with sarcopenia. Eligible subjects aged 65 years and older will be randomized to receive placebo or one of three dose levels of PLH-2301 once daily for 12 weeks.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Male or female people aged 65 years or older at the time of consent
- Diagnosis of sarcopenia based on predefined diagnostic criteria
- Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening
- Stable body weight for at least 3 months prior to screening
- Able to walk independently with or without assistive devices
You likely can't join if
- History of clinically significant neuromuscular or musculoskeletal disorders that could affect muscle function
- Uncontrolled cardiovascular, hepatic, renal, or metabolic disease
- Use of medications known to affect muscle mass or function within the protocol-defined washout period
- Participation in another treatment clinical trial within 3 months prior to screening
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation
See the full eligibility criteria
- Male or female people aged 65 years or older at the time of consent
- Diagnosis of sarcopenia based on predefined diagnostic criteria
- Short Physical Performance Battery (SPPB) total score within the protocol-defined range at screening
- Stable body weight for at least 3 months prior to screening
- Able to walk independently with or without assistive devices
- Willing and able to comply with study procedures
- Provided written informed consent prior to any study-specific procedures
- History of clinically significant neuromuscular or musculoskeletal disorders that could affect muscle function
- Uncontrolled cardiovascular, hepatic, renal, or metabolic disease
- Use of medications known to affect muscle mass or function within the protocol-defined washout period
- Participation in another treatment clinical trial within 3 months prior to screening
- Any medical or psychiatric condition that, in the investigator's opinion, would interfere with study participation
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Seoul, Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seongnam-si, Gyeonggi-do, South Korea; Suwon, Gyeonggi-do, South Korea; Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.